Is Treatment of Vitamin D Deficiency Associated With Resolution of Statin-Induced Muscular Symptoms
Completed · Phase 4 · Has a placebo group
Conditions studied: Myopathic Symptoms
In brief
Statins are a class of drugs that are highly effective at lowering cholesterol levels. However, compliance is often limited by symptoms of muscle pain. The investigators would like to study Vitamin-D deficient individuals who also have muscle pain due to statin use. About 1 billion people are estimated to have low or insufficient levels of vitamin D worldwide. Patients with low or insufficient levels of vitamin D may develop muscle disease. The purpose of this study is to identify if these symptoms are associated with vitamin D deficiency, and most importantly, if treatment of vitamin D deficiency can reduce muscle pain that is caused by statin treatment.
Key facts
- Study ID
- NCT01568255
- Run by
- Cedars-Sinai Medical Center
- People needed
- 11
- Starts
- 2012-03-01
- Expected to finish
- 2019-06-01
- Last updated by the study team
- 2021-06-10
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Female gender (refer to section 4)
- Age > 18, using an effective form of contraception (refer to section 4)
- An indication to be on statin therapy
- Moderate to severe myopathic pain while on Simvastatin
- Serum CK level < 10 x ULN
- Vitamin 25 OH D level < 30 ng/mL (as secondary hyperparathyroidism is triggered below this level)1
- English speaking patients only
- Myopathic pain that cannot be attributed to other medical conditions
- Continue a statin within the CYP3A4 family
- Competent to give informed consent
You may not qualify if…
- Clinical diagnosis of overt vitamin D deficiency: osteomalacia, rickets, hypocalcemia, hypophosphatemia
- Already taking Vitamin D supplements > 1000 IU/day
- Serum creatinine > 2.2 mg/dL within last 6 months
- AST/ALT > 3 x ULN of the local reference range
- Serum CK level > 10 x ULN
- Systolic blood pressure < 100 mmHg
- Albumin adjusted calcium > 2.55 mmol/L or < 2.20 mmol/L
- Renal osteodystrophy
- Malabsorption syndrome
- Metastatic malignancy
- Transplant recipients
- A co-existent diagnosis of renal calculi within the previous 6 months
- A co-existent diagnosis of primary hyperparathyroidism within the previous 6 months
- Recent therapy with corticosteroids within the previous 6 months
- Currently consuming Digoxin, as usage increases risk of hypercalcemia
- Lactating women
Where it is running
- Cedars-Sinai Medical Center — Los Angeles, California, United States
Full record on ClinicalTrials.gov
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